BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP

    MDR report key: 2892228 · Received December 26, 2012

    Report

    Report Number
    2182269-2012-00146
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 30, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE ANGIO-SEAL DEVICE INSTRUCTIONS FOR USE (IFU) CAUTIONS, SHOULD ISCHEMIC SYMPTOMS APPEAR, TREATMENT OPTIONS INCLUDE THROMBOLYSIS, PERCUTANEOUS EXTRACTION OF THE ANCHOR OR FRAGMENTS, OR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    A 6F ANGIO-SEAL VIP WAS SELECTED FOR USE AND DEPLOYED TO SEAL A PUNCTURE IN THE RIGHT COMMON FEMORAL ARTERY, FOLLOWING A PRE-DEPLOYMENT ANGIOGRAM. POST-DEPLOYMENT, THE PATIENT REPORTED PAIN IN THE LEG WHILE STANDING. A PULSE WAS PRESENT WITH VASCULAR INSUFFICIENCY. ULTRASOUND REVEALED ANCHOR MIGRATION AND ARTERIAL OCCLUSION, FOLLOWED BY SURGICAL REMOVAL OF THROMBUS AND A FOREIGN BODY OF PLASTIC MATERIAL, CONSISTENT WITH THE CLOSURE DEVICE, WERE REMOVED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP DEVICE, HEMOSTASIS, VASCULAR MGB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R